510(k) · Cleared

Cleared

4.5 MM LS Facet Compression Device with Polymer Washer, Model LSPW-45-3040

K051949510(k) SpecialCleared Aug 5, 200521-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Triage Medical, Inc. · MRW System, Facet Screw Spinal Device

Cleared on Aug 5, 2005 as substantially equivalent to K043351 (Triage Medical, Inc., 2005) after a 21-day review. Its family tree reaches back 2 generations to 2002.

Decided: Aug 5, 2005
Review: 21 days
Class: Class U
Product code: MRW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K020411 (2002). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK020411 Nuvasive Triad Facet Screw SystemNuvasive, Inc. · 2002
1 generation backK043351 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S…Triage Medical, Inc. · 2005 · Recalled
This deviceK051949 4.5 MM LS Facet Compression Device with Polymer Washer, Model…Triage Medical, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K020411	Nuvasive Triad Facet Screw System	Nuvasive, Inc.	2002	—
−1	K043351	4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N	Triage Medical, Inc.	2005	1
0 (this device)	K051949	4.5 MM LS Facet Compression Device with Polymer Washer, Model LSPW-45-3040	Triage Medical, Inc.	2005	—

FIG. 1 — Lineage of K051949, 2002–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MRW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MRW device

#1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K043351	4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N Summary page 1 …4.5mm LS Facet Compression Device with Polymer Washer is similar in basic design and intended use to the Triage Medical BONE-LOK® 4.5mm Facet Screw, cleared under 510(k) K043351. DEVICE DESCRIPTION The 4,5mm LS Facet Compression Device is a double-helix screw with a compression- locking collar. It is avai…	Triage Medical, Inc.	2005	1

Also cleared against K043351: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K043351.

How does its category compare?

All MRW devices

MRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MRW

7in 2025

2007high 7 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRW

97in 2025

2007high 252 (2022) · low 50 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MRW

3in 2011

2007high 3 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MRW

3in 2025

2007high 62 (2011) · low 0 (2008)2025

MAUDE reports naming product code MRW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	1
2008	3	88	0	0
2009	6	89	0	2
2010	6	108	0	7
2011	3	122	3	62
2012	4	119	0	6
2013	7	110	0	4
2014	0	—	0	1
2015	2	—	0	2
2016	2	—	0	1
2017	1	—	0	4
2018	2	—	0	4
2019	3	90	0	0
2020	0	—	0	0
2021	0	—	0	1
2022	3	252	0	0
2023	3	190	0	1
2024	7	50	0	2
2025	7	97	0	3
2026	5	169	0	—

What is it indicated for?

The 4.5mm LS Facet Compression Device with Polymer Washer is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion. The intended use of the 4.5mm LS Facet Compression Device with Polymer Washer is to stabilize the spine as an aid to…

Read the full statement (125 words)

The intended use of the 4.5mm LS Facet Compression Device with Polymer Washer is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm LS Facet Compression Device with Polymer Washer is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from Li to Si.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051949 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051949: 4.5 MM LS Facet Compression Device with Polymer Washer, Model LSPW-45-3040.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051949

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026